Portable medical information analyzers are known in the art. For example, medical information analyzers are disclosed in the following U.S. Pat. Nos. 6,206,829; 6,171,264; 6,171,237; 6,162,180; 6,160,478; 6,149,585; 6,108,578; 6,102,856; 6,100,806; 6,093,146; 6,072,396; 6,067,466; 6,049,794; 6,047,203; 6,039,688; 6,011,989; 5,971,921; 5,959,529; 5,942,986; 5,941,829; 5,931,791; 5,921,938; 5,919,141; 5,878,746; 5,876,351; 5,873,369; 5,855,550; 5,840,020; 5,782,878; 5,772,586; 5,735,285; 5,704,364; 5,678,562; 5,564,429; 5,544,661; 4,909,260, incorporated herein by reference.
In addition, the following references are also known in the art: Russian Application No. 98106704/13 M.C. A615b5/02, A61B5/0452 published on Oct. 2, 2000. In addition Russian application No. 98103717/14 M. cl. A61B5/0452 published on Oct. 1, 2000; Russian Patent Application No. 97113351/14 M. cl. A61B5/02 published on Feb. 6, 1999; and finally, Russian Patent Application No. 93016579.
All of these references have one or more significant disadvantages. First, there are few parameters being analyzed in that only one parameter may be analyzed at one time instead of multiple parameters. Second, there is no real time complex approach to a patient""s complex present state evaluation because one or more of the above references require the direct participation of an expert evaluating the parameters. Third, many of the devices described by the prior art require the patient to be located adjacent to the evaluation device. Since evaluation devices may be the size of a personal computer, this limits the availability for patients to use these monitoring devices.
In addition, in all of the previous models, the ECG waves were read directly and then analyzed. In the present invention a few preliminary points are analyzed first and then the ECG information is reconstructed in the form of a QRS wave. In addition, this invention involves a predictive model that uses one or more parameters derived from this QRS wave to determine the possibility of the user experiencing an abnormal medical occurrence.
Thus, in the past, patients may have been reluctant to use these medical information analyzers because they were too large and cumbersome. Furthermore, doctors or other medical professionals may have been reluctant to prescribe the use of these portable medical information analyzers because they might provide insufficient, or incorrect medical information.
For example, this medical information analyzer could be used to detect heart arrhythmias. Arrhythmias are a disturbance in the rate or rhythm of the heartbeat. Various arrhythmias can be symptoms of serious heart disorders; however, they are usually of no medical significance except in the presence of additional symptoms.
The heart""s rhythm is controlled by an electrical impulse that is generated from a clump of tissue on the right atrium called the sinoatrial node, often referred to as the heart""s natural pacemaker. It travels to a second clump of tissue called the atrioventricular node and then to the ventricles. Bradycardia, or slow heartbeat, is often present in athletes. It may, however, indicate conduction problems, especially in older people. In one type of bradycardia, called sinoatrial or atrioventricular block, or heart block, rhythm can be maintained by implanted electrodes that act as artificial pacemakers. Drugs, caffeine, anemia, shock, and emotional upset can precipitate tachycardia or heartbeat faster than 100 beats per minute in the adult. It may also be a sign of over activity of the thyroid gland or underlying disease.
Flutters, and the even faster fibrillations, are rapid, uncoordinated contractions of the atrial or ventricular muscles that usually accompany heart disorders. Atrial fibrillation may be idiopathic, the result of rheumatic mitral valve disease (see rheumatic fever) in young people or hypertensive heart disease (see hypertension) and arteriosclerotic heart diseases (see arteriosclerosis) in older people. It may result in a rapid pulse rate and may be associated with thrombus formation in the atria and a risk of embolization to the brain (stroke) or other organs.
Atrial fibrillation is often treated with digitalis. Ventricular fibrillation is a sign of the terminal stage of heart failure and is usually fatal unless defibrillation is achieved by immediate direct-current defibrillation. Some tachycardias can be managed by the implantation in the upper chest of small defibrillators that sense dangerous fibrillations and administer an electric shock to the heart to restore normal rhythm. The Columbia Encyclopedia, Sixth Edition. 2001.
These problems are overcome by providing a new system and process for evaluating a medical condition of a patient by providing an improved portable medical information analyzer and an improved central information-processing device in one system.
One object of this invention is to provide a process for calculating a QRS line based upon a limited number of preliminary points or indicia taken from an individual.
Another object of the invention is to provide an accurate estimator of the future probability of an abnormal medical condition by using a patient""s ECG reading in a customized algorithm to determine the patient""s risk for incurring an abnormal medical condition.
Still another object of the invention is to provide a portable information device that is designed to receive signals from a user wherein these signals are then analyzed as described in the first two objects of the invention.
The invention relates to a portable medical information-analyzing device that may comprise at least one sensor for extracting medical information from a user. The user could either be a person or an animal.
This device also comprises at least one transceiver for transmitting this medical information from the user and at least one external interface to control external equipment that relates to the user. In addition, the transceiver is designed to receive information from the information-processing device. Thus, this portable information device sends this information onto an information-processing device and receives information from it. The information-processing device comprises at least one transceiver for receiving and transmitting the medical information from and to the portable information device.
There is also at least one medical information analyzer, which calculates a series of medical-based parameters from this medical information. The system also includes at least one data store in communication with the medical information analyzer. The data store stores a set of predetermined data on these medical-based parameters. There is also at least one parameter analyzer, which compares a set of predetermined data in the data store with the medical-based parameters calculated from this medical information.
Once this information has been determined, it is sent to an abnormality identifier, which then determines whether these parameters are out of line with the present set of parameters, and determines a risk assessment, which is used to determine the type of alarm used to signal the user. Finally, there is also an alarm, which sends an alarm signal to the user when the medical based parameter analyzer determines a medical abnormality based upon a comparison of the set of predetermined data with the medical information.
The invention also relates to a process for analyzing the medical condition of the user. In this case, the process can either operate using the device described above or use another type device such as a personal computer. The process includes the first step of gathering medical information from a user. Next, the process involves sending this information to a medical information analyzer. The medical information analyzer extracts particular points on a QRS wave out of the ECG information, analyzes this information, and then reconstructs the QRS wave so that it does not have any noise. Next, this analyzer breaks this information down into a plurality of discrete parameters. These parameters are: 1) pulse rate; 2) immediate alteration of pulse rate; 3) Rxe2x80x94R interval; 4) premature beats; 5) group of premature beats; 6) atrial fibrillation flutter; 7) ST-segment depression/elevation; 8) T-wave inversion; 9) width of Q-wave; 10) Ratio of Amplitude of Q-wave to Amplitude of R-wave; 11) Amplitude of R wave; 12) Width of QT-interval; 13) Width of QRS complex; 14) Width of PQ interval; and 15) Standard Deviation of the average normal-to-normal Rxe2x80x94R intervals. These parameters are then compared with a set of pre-set parameters to determine whether a user is experiencing abnormal symptoms. Depending upon the value of the calculated parameter, the parameter definition, and the risk analysis, an alarm may be activated to signal the user that the user has entered an abnormal medical condition.
To predict whether the user will experience an abnormal medical condition, such as the complex risk of sudden cardiac death, a plurality of parameters are compiled in a formula. These parameters relate to the previously mentioned parameters in that these parameters involve the ST init., which is the ST segment level before the observation begins; ST meas., which is the ST segment level at the current movement; ST thresh., which is the ST segment threshold at normal levels; QT meas. which is the QT interval duration at the current moment; QT norm., which is the QT interval normal duration.
Thus, this formula builds upon the parameters that are calculated when determining whether the user is experiencing an abnormal medical condition.
In addition, this type of risk can be adjusted for each user so that the system learns the boundaries for each user. Ultimately, once the abnormal medical condition has been determined, the system determines which alarm to activate to warn the user. This information in the form of the alarm is then communicated to the portable information device to control external equipment or stimuli at the user based upon the medical and environmental information.